In
December 2019, EMA and its European and international partners launched a pilot
programme to share information on GMP inspections of manufacturers of sterile
medicines located outside the participating countries and to organise joint
inspections of manufacturing sites of common interest. The products in scope
include sterile medicines for human use of chemical origin and certain therapeutic
biotechnology -derived products, such as monoclonal antibodies and recombinant
proteins. Vaccines, cell and gene therapies and plasma derived pharmaceuticals
are currently out of the scope of this pilot. For the terms of reference,
objectives and full scope.
This
initiative builds on the success and experience with the API inspection
programme.
See:
https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/international-collaboration-gmp-inspections
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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